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New Osteoporosis Treatments on the Horizon

National foundation issues report

March 8, 2016

The National Osteoporosis Foundation (NOF), in a joint effort with the Pharmaceutical Research and Manufacturers of America, has released a report on new therapies being developed for the treatment of osteoporosis. The publication examines the nationwide effects of the disease and explores how new medications can improve and save lives.

Nearly 54 million of the 99 million Americans over the age of 50 years in the U.S. have been diagnosed with osteoporosis or low bone mass, according to the NOF, and two million osteoporosis-related fractures are reported each year. The annual cost of osteoporosis is estimated at $19 billion and is expected to increase to $25 billion by 2025.

In patients with osteoporosis, bone loss occurs when bone resorption occurs at a faster rate than that of bone formation, resulting in decreased bone density. Medications in pharma pipelines are using novel approaches to correct this imbalance or are investigating new ways to administer treatment, according to the NOF. These medications include the following:

An oral treatment that selectively inhibits cathepsin K, the primary enzyme on osteoclasts that digests proteins during bone resorption, is in development for the treatment of osteoporosis. Osteoclasts are cells that resorb bone and secrete signaling factors to stimulate osteoblasts, cells that form bone. Abnormal cathepsin activity may be involved in multiple bone disorders, including osteoporosis.

A monoclonal antibody that binds to and inhibits the action of sclerostin, a protein encoded by the SOST gene, is another potential osteoporosis treatment. Mutations in sclerostin have been associated with abnormal bone growth. Inhibiting sclerostin may play a critical role in increasing bone formation and decreasing bone breakdown.

A synthetic analogue of human parathyroid hormone-related protein (hPTHrP) is in development for the treatment of postmenopausal osteoporosis. hPTHrP is thought to be a critical cytokine for promoting new bone formation. The investigational medication is designed to build bone rapidly without inducing hypercalcemia or significant bone erosion.

Transdermal patches are in development to administer the active pharmaceutical ingredient from previously approved injectable treatments for osteoporosis. Transdermal systems use biodegradable microneedles administered via a patch. Transdermal patches are expected to combine the convenience of a transdermal patch formulation with the speed of a standard injection.

In addition, researchers are exploring new approaches to attacking osteoporosis based on new scientific discoveries. Some recent findings include the identification of a gene for high bone mass and its signaling pathway; the understanding that excess remodeling (the process of bone resorption and bone formation) plays a key role in making bones fragile; and the discovery of biomarkers for the rate of bone remodeling, which can help identify people who are at the greatest risk from osteoporosis.

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